Method of administration: Oral.Dosage:
The power of enzyme alpha-amylase is expressed in U. IEPe. (Enzyme weight hydrolyses 1 mg of soluble starch in 10 seconds at 37°C). Infants and children up to 3 years of age (15 kg): 1 teaspoon (5 ml) 3 times a day (5 ml of syrup contain U. IEPC 1000)
Children over 3 years of age (> 15 kg): 1 tablespoon (10 ml) 3 times per day (10 ml syrup contain U.CEIP 2000)
Adults: 1 tablespoon (15 ml) 3 times a day. (15 ml syrup contain 3.000 U.CEIP).

4.3 Contra – indications

Hypersensitivity to alpha-amylase or any of the excipients.

4.4 Special warnings and precautions for use

Warnings:
Due to the presence of sucrose, patients with rare hereditary problems of intolerance the fructose, glucose-galactose malabsorption or sucrase- isomaltase insufficiency, should not take this medicine. Diabetics should take into account that a teaspoon (5 ml) contains 3.2 g of sucrose and a tablespoon (15 ml) contains 9.6 g sucrose. Maxilase syrup contains sunset yellow (Ell0) which may cause allergic reactions. Maxilase syrup contains sodium parahydroxybenzoate and methyl parahydroxybenzoate sodium propyl which may cause allergic reactions (possibly delayed).

Special precautions for use:
In the case of persistence or appearance of new symptoms (severe sore throat.headaches. nausea, vomiting) or in case of associated fever, must be reevaluated to therapeutic strategy.
This medicine should not be used for long periods of time without the physician advice

4.5 Drug interactions and other forms of interaction

There are no known interactions of accounts between alpha amylase and otlu medicines.

4.6 Pregnancy and lactation

As regards alpha-amylase, no clinical data is available on the pregnancy Animal studies revealed no harmful effects direct or indirect on pregnancy, embryo-fetal development and delivery. This medecine should only be prescribed to pregnant women with extreme caution
Lactation
It is not known if the alpha amylase passes into human breast milk. This medicine should be avoided the for use during breastfeeding.

4.7 Effects on ability to drive and use machines

Not relevant

4.8 Undesirable effects

Adverse reactions were positioned according to the organ system classification
– Class and frequency using the following convention: very common (~ 1/10);
Common (~ 1/100, <1/10); uncommon (~ 1/1000, <1/100); rare (~ 1/10000 < 1/1000); very rare «1/10000).
Skin and subcutaneous tissue disorders:
– Very rare: urticaria type of eruptions.

4.9 Overdose

No case of overdose of this medicine.
In case of accidental ingestion, should start appropriate treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic properties:

pharmacotherapeutic group: 9.5 locomotor apparatus. anti-inflammatory enzymes.
Enzymatic Preparation of anti-edematous and anti-inflammatory activity. The mode of action of alpha-amylase in inflammatory edema is characterized by:
– Hydrolysis with polysaccharides inflammatory exudate, making it more fluid
– Inhibition of abnormal capillary permeability (which is increased during the first stage of inflammation) by decreasing the output of liquids from vessels allowing easier edema resorption.

5.2 Pharmacokinetic properties

Alpha-amylase is an endoamylase that catalyzes the starch molecules on the links of glucosides so there are no pharmacokinetic data.